Cleared Traditional

K832408 - STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM

K832408 is the FDA 510(k) clearance for STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM by American Dade. It is a Class 2 Chemistry device (product code LCR) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K832408 · American Dade · Chemistry device

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Aug 1983

Decision

36d

Days

Class 2

Risk

K832408 is an FDA 510(k) clearance for the STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on August 26, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3900 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Dade devices

Submission Details

510(k) Number	K832408 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 21, 1983
Decision Date	August 26, 1983
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

52d faster than avg

Panel avg: 88d · This submission: 36d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LCR Fluorescent Immunoassay, Tobramycin
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.3900

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCR Fluorescent Immunoassay, Tobramycin

All 10

Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K832408.

OPUS(R) TOBRAMYCIN

K911940 · Pb Diagnostic Systems, Inc. · Jul 1991

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

K911613 · Exmoor Plastics , Ltd. · Jun 1991

DU PONT TOBRAMYCIN ASSAY REAGENTS

K850058 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985

NEEDLE HOLDERS

K822197 · Kelleher Corp. · Aug 1982

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA

K821542 · Electro-Nucleonics Laboratories, Inc. · Jun 1982

ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY

K820130 · Syva Co. · Feb 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832408

American Dade

Mchenry, IL · US

Regulatory profile

149 submissions 149 cleared

100% clearance rate · Active in Chemistry

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